CN114616007B - 用于使用输注泵系统补偿管应力松弛效应的系统和方法 - Google Patents
用于使用输注泵系统补偿管应力松弛效应的系统和方法 Download PDFInfo
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- CN114616007B CN114616007B CN202080076144.9A CN202080076144A CN114616007B CN 114616007 B CN114616007 B CN 114616007B CN 202080076144 A CN202080076144 A CN 202080076144A CN 114616007 B CN114616007 B CN 114616007B
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Abstract
一种输注泵包括:施用套件,其被配置成在输注液供应与输注套件之间提供流体路径;至少一个压力传感器,其被配置成感测施用套件内的输注液的压力;以及控制单元,其被配置成监测感测到的压力并对所监测的压力应用计算的皮重调整,以补偿施用套件内可观察到的作为应力松弛的结果的压力衰减。
Description
相关申请
本申请要求于2019年11月4日提交的美国临时申请第62/930,341号的权益,该美国临时申请的全部内容在此通过引用并入本文中。
技术领域
本公开内容总体上涉及输注泵系统,并且更具体地,涉及用于使用输注泵系统补偿管应力松弛效应的系统和方法。
背景技术
各种类型的输注泵已经用于管理给患者输送和分配规定量或剂量的药物、流体、流体状物质或药剂(在本文中,统称为“输注液”)。输注泵通过在延长的时间段内精确地输送输注液而提供了优于手动施用的显著优点。输注泵特别适用于治疗需要定期药理干预的疾病和病症,包括癌症、糖尿病以及血管、神经和代谢方面的病症。输注泵还增强了保健提供者输送麻醉和控制疼痛的能力。输注泵用于各种环境,包括用于医院、疗养院和其他短期和长期医疗设施,以及用于住宅护理环境。输注泵的类型包括可移动泵、大容量泵、患者自控镇痛泵(PCA)、弹性泵、注射器泵、肠内泵以及胰岛素泵。输注泵可以用于通过各种输送方法施用药物,这些输送方法包括静脉内、腹膜内、动脉内、皮内、皮下、紧邻神经输送,以及输送到手术中部位、硬膜外腔或蛛网膜下腔。
在通常称为“蠕动”泵系统的特定类型的输注泵系统中,向患者输送输注液通常通过使用输注施用套件来完成,该输注施用套件通常在使用后被处理掉并且可以与控制输注液的流量的泵协作地为输注液提供从储存器(比如静脉内袋或“IV”袋)至患者的流体路径(例如,管)。蠕动输注泵包含蠕动泵送机构,该蠕动泵送机构可以通过以波浪状运动重复地和暂时地阻塞施用套件的管的连续部段来发挥作用。“大容量泵”系统或“LVP”系统是具有如上所述的相关部件的常见类型的蠕动泵;在一些出版物中,术语“容积泵”也可以不同地用于指代LVP或蠕动泵。
LVP通常包括被配置成监测管内输注液的流体压力的一个或更多个传感器。例如,LVP通常包括:“下游压力传感器”,其被配置成检测对从LVP向外的规定输注液流的不希望的阻塞;以及“上游压力传感器”,其被配置成检测储存器何时为空以及/或者泵送机构的上游何时出现其他的异常流体压力。这些传感器通常必须提供相对高的可靠性和高灵敏度,以确保将期望的输注液的量输送给患者。
对管内压力的精确检测可能因管本身的特性而变得复杂。特别地,在静脉输注管的构造中所使用的某些材料可能经受通常被称为“应力松弛”的现象。应力松弛通常是指当管保持在压力下时管壁中的可观察应力的衰减,从而使得难以随时间推移精确地监测流体压力数据。通常,在移除例如来自作用在其上的蠕动泵送机构的压力负载时,管回到其原始形状。随着时间的推移,应力由于管材料特性的变化而松弛,这产生了由压力传感器测量的输注液压力下降的假象。
维持导管通畅并且使阻塞最小化对提高患者安全性和改善治疗效果很重要。为了告警用户阻塞的存在,许多输注泵系统例如LVP具有预设的阻塞压力阈值。一旦由下游压力传感器感测到的压力超过预设限制,就会触发阻塞警报。尽管现代输注系统通常非常擅长检测阻塞,但在较低压力下,作为应力松弛的结果的不正确压力检测可能导致特定输注系统无法检测到阻塞。较高的阻塞压力增加了患者遭遇灾难性组织损伤或器官损伤的可能性。因此,相对精确的压力检测对于输注泵的安全性能至关重要。
本公开内容解决了这些问题。
发明内容
本公开内容的实施方式提供了用于在对通过施用套件的聚合物管的流体压力的感测和测量中补偿管应力松弛效应从而使得能够进行较安全和更可靠的输注液流体压力的感测和测量并且总体上减少用于检测阻塞所需的时间量的系统和方法。
本公开内容的实施方式提供了一种输注泵,所述输注泵包括:施用套件,其被配置成在输注液供应与输注套件之间提供流体路径;至少一个压力传感器,其被配置成感测施用套件内的输注液的压力;以及控制单元,其被配置成监测感测到的压力并对该监测的压力应用计算的皮重调整,以补偿施用套件内可观察到的作为应力松弛的结果的压力衰减。
在实施方式中,输注泵还包括泵驱动机构,所述泵驱动机构被配置成通过暂时地压缩施用套件的部段来迫压输注液通过施用套件。在实施方式中,泵驱动机构包括蠕动驱动机构。在实施方式中,至少一个压力传感器包括定位在泵驱动机构上游的上游压力传感器、定位在泵驱动机构下游的下游压力传感器、上游压力传感器与下游压力传感器的组合。在实施方式中,控制单元部分地监测感测到的压力以检测阻塞的存在。
在实施方式中,皮重调整由控制单元至少部分地基于由至少一个压力传感器收集的数据来计算。在实施方式中,皮重调整由非线性函数表示。在实施方式中,皮重调整由多项式方程表示。在实施方式中,皮重调整由以下方程表示:R(t)=C0 R(t)=C0+C1·t^-τ1+C2^(-t/τ2)+C3^(-t/τ3),其中,R等于作为时间(t)的函数的应力松弛,τ1、τ2、τ3、C2和C3表示硬件特征常数,并且C0和C1表示拟合常数。在实施方式中,在皮重调整被控制单元应用之前将其与接受标准进行比较。
本公开内容的实施方式提供了一种输注泵,所述输注泵包括:包括驱动机构的输注泵、至少一个压力传感器和控制单元;以及施用套件,其被配置成在输注液供应与输注套件之间提供流体路径,其中,输注泵被配置成监测由至少一个压力传感器感测到的压力并对所监测的压力应用计算的皮重调整,以补偿施用套件内可观察到的作为应力松弛的结果的压力衰减。
本公开内容的另一实施方式提供了一种方法,所述方法包括:经由一个或更多个传感器监测施用套件的上游压力和下游压力中的至少一者;至少部分地基于从一个或更多个传感器收集的数据来计算皮重调整;确定所计算的皮重调整是否满足接受标准;以及将计算的皮重调整应用于从一个或更多个传感器收集的数据,以补偿施用套件内可观察到的作为应力松弛的结果的应力衰减。
以上概述不意在对本公开内容的每个示出的实施方式或每个实现方式进行描述。附图和随后的详细描述更具体地例示了这些实施方式。
附图说明
考虑以下结合附图对本公开内容的各种实施方式的详细描述,可以更完全地理解本公开内容,在附图中:
图1是描绘了根据本公开内容的实施方式的用于患者的蠕动输注泵系统的示意性透视图。
图2A是描绘了根据本公开内容的实施方式的图1的系统中的蠕动输注泵的各部分的示意性透视图,特别地,示出了泵的组件接纳部和接纳部门。
图2B是描绘了根据本公开内容的实施方式的图2A的蠕动输注泵的各部分的示意性透视图,其中,施用套件的一部分由组件接纳部接纳。
图3是描绘了根据本公开内容的实施方式的图1的系统中的蠕动输注泵的各种部件和电路的示意图。
图4是描绘了根据本公开内容的实施方式的施用套件的管壁内的应力分布的截面图。
图5是描绘了根据本公开内容的实施方式的在一段时间内施用套件管壁中的给定点处作为应力松弛的结果的应力非线性退化的图形表示。
图6是描绘了根据本公开内容的实施方式的由传感器响应于施用套件的管壁外部在一段时间内测量的作为应力松弛的结果的反作用力的图形表示。
图7是描绘了使用最小二乘法进行的应力松弛函数的计算或曲线拟合的图形表示。
图8是描绘了根据本公开内容的实施方式的用于应对应力松弛的补偿压力传感器值、未补偿压力传感器值和来自被配置成直接监测输注液压力的外部源的数据之间的比较的图形表示。
图9是描绘了根据本公开内容的实施方式的用于在输注压力的测量中补偿应力松弛的方法的流程图。
尽管本公开内容的实施方式能够修改为各种改型和替代形式,但是这些实施方式的在附图中以示例示出的细节将被详细描述。然而,应当理解的是,意图不是将本公开内容限制于所描述的特定的实施方式。相反,意图是覆盖落入由权利要求书所限定的主题的精神和范围内的所有改型、等同方案和替代方案。
具体实施方式
图1是供患者使用的输注泵系统100的示例性实施方式的示意性透视图,其包括蠕动泵102(更具体地,大容量泵或LVP 102)和施用套件104,该施用套件104可以是一次性的,并且被定结构和被配置成以可操作且可移除的方式联接至泵102。施用套件104被示意性地示出为提供从IV袋106至输注套件或管108的流体路径,输注套件或管108最终将输注液输送至患者110。在图1中,泵102的接纳部门112被示出为处于闭合配置,并且施用套件104被示出为未联接至泵102。
为了更全面地示出泵102的各种部件,图2A和图2B示出了泵102的部分描绘。具体地,仅示出了泵102的靠近组件接纳部114和接纳部门112的部分。组件接纳部114可以被配置成接纳施用套件104的组件116,使得施用套件104由此以可操作的方式联接至泵102。特别地,图2B是图2A的泵102的各部分的示意性透视图,其中,组件116被组件接纳部114接纳或以可移除的方式安装在组件接纳部114中。接纳部门112可以打开或关闭以允许或阻挡通向组件接纳部114的入口。在图2A至图2B两者中,泵102的接纳部门112被示出为处于打开位置。
蠕动泵驱动机构122可以位于组件接纳部114中。施用套件104的组件116可以被配置成和被定结构成定位施用套件104的各元件,包括定位与蠕动驱动机构122处于操作关系的组件116的管120的居中定位部段。管120的居中定位部段可以由弹性材料形成,该弹性材料适合于被泵102的蠕动驱动机构122压缩(并且从压缩中恢复)。蠕动驱动机构122可以包括管接合构件118(有时称为“指状件”),管接合构件118被配置成通过以波浪状的运动重复地且暂时地挤压或阻塞管120的居中定位部段来迫压、推动、迫使或以其他方式将流体运送通过施用套件104。
图2A至图2B描绘了包括十二个管接合构件118的泵102;在其他实施方式中,可以存在更少的或附加的管接合构件。通常,管接合构件118的数目确定了对于每个泵循环的流体输送量或被输送流体的“包尺寸”。例如,在实施方式中,流体的包尺寸可以是约150μL;也可以设想其他包尺寸。
在施用套件104内生成的流体压力通常能够经由施用套件104的各部分的弹性拉伸或形变来检测。例如,在实施方式中,施用套件104内的在管接合构件118的上游和下游的流体压力能够分别由上游压力传感器124和下游压力传感器126来检测。如图2A至图2B中描绘的,上游压力传感器124和下游压力传感器126可以定位在组件接纳部114内管接合构件118的每个相应侧部上。也设想了传感器的其他位置、组合和布置。
图3是系统100中的输注泵102的各种部件和电路的示意图。管接合构件118可以由蠕动驱动机构122驱动,蠕动驱动机构122可以由具有存储器129的控制单元128控制。控制单元128可以接收来自键盘130和其他输入装置、传感器和监测器的输入,例如接收来自上游压力传感器124和下游压力传感器126的输入。控制单元128还可以提供输出以及接收来自图形用户界面132诸如例如触摸屏输入和显示系统的输入。
在实施方式中,控制单元128可以经由相应的上游压力传感器124和下游压力传感器126来连续地感测上游压力和下游压力,以监测阻塞和可以指示非正常操作的其他输注液压力。对管108内的输注液压力的精确检测可能因管108本身的特性而变得复杂。特别地,组件116的可以由合适的可压缩弹性材料例如有机硅、聚氯乙烯、聚氨酯、胶乳或橡胶构成的居中定位管部段120可能经受通常被称为应力松弛的现象。应力松弛通常是指当管部段120保持在压力下时管部段120中可观察应力的非线性衰减,从而使得难以如上所述随时间推移精确地监测输注液压力数据。
图4描绘了初始流体加压之后管108的横截面内的初始应力分布。因此,管108在点P处的横截面内存在有限应力。图5描绘了在一段时间内点P处的作为管108中应力松弛的结果的应力非线性退化。图6描绘了由上游压力传感器124或下游压力传感器126在相同时间段内测量的对应的反作用力。如图5和图6所描绘的,应当理解和领会,随着时间的推移,管108中的应力松弛,这产生了由压力传感器124和/或126测量的输注液压力下降的假象。在一些情况下,应力和对应的反作用力与初始应力和对应的反作用力相比可以减少例如超过20%。这些差异可能造成泵102运行期间输注液压力监测的显著误差。使问题进一步复杂化的是,管108的材料通常在去除压力负载时回到其原始形状。
本公开内容的实施方式通过对所谓的“皮重(tare)”值的连续、非线性调整来补偿施用套件104中的管应力松弛效应,该“皮重”值表示由与处于未加压状态下(即,当输注液处于环境压力条件下并且不受例如管接合构件118的操作的影响时)的输注液相关联的压力传感器124和/或126所测量的力的大小。在一些实施方式中,在操作期间皮重可以基于函数随时间进行调整以补偿应力松弛效应。在一些实施方式中,皮重可以在移除管材料108上的压力负载时(例如,管接合构件118的操作中的输注泵循环完成时)被重新设置成其初始值,以应对管108的材料回到其原始形状。
在实施方式中,可以根据以下多项式方程提供对应力松弛效应的补偿:
其中,R等于作为时间(t)的函数的应力松弛,τ1、τ2、τ3、C2和C3表示硬件特征常数,并且C0、C1表示由控制单元128确定的用于近似对于初始试验时间段内在恒定输注液压力下的可测量应力松弛的应力松弛函数的拟合常数。
例如,在实施方式中,τ1、τ2、τ3、C2和C3的值是在操作之前通过硬件描述开发的预定常数。由上游传感器124和/或下游传感器126在初始试验时间段(例如,500秒)内收集的数据可以由控制单元128使用以在系统100中开始输注操作之前计算C0和C1的值,以便将应力松弛函数(即,皮重调整)拟合至由传感器124和/或126观察到的数据。此后,控制单元128可以根据随时间变化的应力松弛函数来周期性地或连续地调整皮重。
因此应当理解和领会,皮重函数通过应对应力松弛而改进了对输注液压力的估计,否则应力松弛将造成测量中的误差。通过在每次输注前计算C0和C1的值,皮重函数还可以应对附加地变化源,例如可能导致初始反作用力即应力松弛之前的反作用力更高或更低的泵尺寸变化。这可以进一步改进对输注液压力的估计并且可以改进检测阻塞的能力。
图7以图形的方式描绘了通过最小二乘曲线拟合方法计算常数C0和C1。在接纳部门112锁闭的时间(t=0)与指定的结束时间(t=500秒)之间,控制单元128对常数C0、C1、C2和C3进行调整,直到应力松弛函数与观察到的数据匹配。尽管在本实施方式中使用了500秒的初始试验时间段,但也可以使用其他的初始试验时间段。例如,在实施方式中,初始试验时间段可以短至五秒。
在指定的结束时间之后,控制单元128将应力松弛函数应用于由一个或更多个传感器124/126所测量的值以消除应力松弛的影响。在一些实施方式中,可以在操作期间对照预定义的接受标准来检查拟合常数C0、C1、C2和C3,以确保算法令人满意地执行。如果不满足接受标准,则可以使用默认应力松弛曲线,从而应对基线水平的应力松弛。
图8描绘了以下之间的图形比较:用于应对应力松弛的补偿压力传感器值(“[如图所示]”);未补偿压力传感器值(“[如图所示]”)以及来自被配置成直接监测输注液压力的外部源的数据(“[如图所示]”)。如所描绘的,补偿压力传感器与输注液的实际流体压力密切对应。
参照图9,根据本公开内容的实施方式描绘了用于补偿施用套件104内的压力测量以应对应力松弛效应的方法200。该方法开始于S202。在S204处,系统100经由一个或更多个传感器124/126来监测上游压力和下游压力中的至少一者。在S206处,控制单元128如上所述利用由一个或更多个传感器124/126收集的数据来计算作为时间的函数的非线性皮重调整。在S208处,进行以下确定:在S206处计算的非线性皮重调整是否满足预定义的接受标准。如果所计算的非线性皮重调整满足预定义的接受标准,则在S210处,将所计算的非线性皮重调整应用于由一个或更多个传感器124/126收集的数据以补偿应力松弛。如果所计算的非线性皮重调整不满足预定义的接受标准,则在S212处将默认非线性皮重调整应用于由一个或更多个传感器124/126收集的数据。在S216处,处理完成。
因此,本公开内容的实施方式提供了用于在对相对于施用套件的管的输注液压力的测量中补偿应力松弛的系统和方法,从而使得能够进行较安全和更可靠的输注液流体压力测量并且总体上减少检测阻塞所需的时间量。
本文中已经描述了系统、装置和方法的各种实施方式。这些实施方式仅以示例的方式给出,并且不意在限制所要求保护的主题的范围。此外,应当理解,已经描述的实施方式的各种特征可以以各种方式组合从而可能产生附加的实施方式。此外,虽然已经描述了各种材料、尺寸、形状、配置和位置等以用于所公开的实施方式,但是在不超出所要求保护的主题的范围的情况下,可以利用除了所公开的那些以外的其它材料、尺寸、形状、构型和位置等。
相关领域的普通技术人员将认识到,本发明的主题可以包括比以上通过示例所描述的任何单独实施方式中所示出的更少的特征。本文中描述的实施方式并不意味着是对本发明的主题的各种特征可以被组合的方式的穷举性呈现。因此,实施方式不是特征的互斥组合;相反,如本领域普通技术人员所理解的,如果不违背本发明的主题的教导,各种实施方式可以包括从不同的单独的实施方式中选择的不同的单独的特征的组合。此外,除非另有说明,否则关于实施方式描述的元件可以在其他实施方式中实现,即使在这类实施方式中没有描述。
尽管从属权利要求在权利要求中可以涉及与一个或更多个其它权利要求的特定组合,但是其他实施方式还可以包括该从属权利要求与每个其它从属权利要求的主题的组合或者一个或更多个特征与其他从属权利要求或独立权利要求的组合。除非说明不旨在提出特定组合或该特定的组合与本发明的主题的公开内容相反,否则本文提出了这样的组合。
上文通过参引文献的任何合并被限制成使得不合并与本文中的明确公开内容相反的主题。上文通过参引文献的任何合并还被限制成使得包含在文献中的权利要求不能通过参引并入本文中。上文通过参引文献的任何合并还被限制成使得在文献中提供的任何限定不通过参引并入本文中,除非明确地包括在本文中。
出于解释权利要求的目的,明确意图的是,除非在权利要求中叙述了特定术语“用于……的装置”或“用于……的步骤”,否则不援引35U.S.C.§112(f)的规定。
Claims (7)
1.一种输注系统,所述输注系统包括:
施用套件,其被配置成在输注液供应与输注套件之间提供流体路径;
输注泵,其包括:
至少一个压力传感器,其被配置成感测所述施用套件内的输注液的压力;以及
控制单元,其被配置成监测所感测到的压力并对所监测的压力应用连续、非线性的计算的皮重调整,以补偿所述施用套件内能够观察到的作为应力松弛的结果的压力衰减,其中,所述皮重调整由以下方程表示:R(t)=C0 R(t)=C0+C1t^-τ1+C2^(-t/τ2)+C3^(-t/τ3),其中,R等于作为时间(t)的函数的所述应力松弛,τ1、τ2、τ3、C2和C3表示硬件特征常数,并且C0和C1表示拟合常数。
2.根据权利要求1所述的输注系统,还包括泵驱动机构,所述泵驱动机构被配置成通过暂时地压缩所述施用套件的部段来迫压输注液通过所述施用套件。
3.根据权利要求2所述的输注系统,其中,所述泵驱动机构包括蠕动驱动机构。
4.根据权利要求2所述的输注系统,其中,所述至少一个压力传感器包括定位在所述泵驱动机构上游的上游压力传感器、定位在所述泵驱动机构下游的下游压力传感器、或所述上游压力传感器与所述下游压力传感器的组合。
5.根据权利要求1所述的输注系统,其中,所述控制单元部分地监测所感测到的压力以检测阻塞的存在。
6.根据权利要求1所述的输注系统,其中,所述皮重调整由所述控制单元至少部分地基于由所述至少一个压力传感器收集的数据来计算。
7.根据权利要求1所述的输注系统,其中,在所述皮重调整被所述控制单元应用之前将其与接受标准进行比较。
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US20240123139A1 (en) * | 2022-10-14 | 2024-04-18 | Fluke Corporation | Compensation of pressure driven leakage while using high precision volumetric pumps |
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AU2020378235A1 (en) | 2022-05-26 |
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US20220387709A1 (en) | 2022-12-08 |
EP4054679A1 (en) | 2022-09-14 |
WO2021092616A1 (en) | 2021-05-14 |
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